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Trial record 36 of 92 for:    Recruiting Studies | fecal microbiota transplantation

Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

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ClinicalTrials.gov Identifier: NCT02543866
Recruitment Status : Recruiting
First Posted : September 7, 2015
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Danielle Zerr, Seattle Children's Hospital

Brief Summary:

This protocol will evaluate fecal microbiota transplantation (FMT) as a strategy to eradicate intestinal colonization of extended-spectrum resistant (ESC-R) Enterobacteriaceae in pediatric patients.

FMT will be performed on subjects with a history of at least one infection due to ESC-R Enterobacteriaceae.

This protocol aims to determine the feasibility, safety, tolerability, and potential efficacy of FMT in pediatric patients with a history of ESC-R Enterobacteriaceae.


Condition or disease Intervention/treatment Phase
Infection Resistant to Drugs Biological: Fecal Microbiota Transplantation Phase 1

Detailed Description:
This is a prospective pilot study of fecal microbiota transplantation in pediatric patients with a history of ESC-R Enterobacteriaceae. Subjects who meet inclusion/exclusion criteria and provide written, informed consent will undergo screening studies and provide a pre-FMT stool sample to confirm intestinal carriage of ESC-R Enterobacteriaceae. The FMT will be administered by nasogastric tube in the outpatient setting by trained personnel. The subjects will be monitored for potential adverse events, recurrence of MDRO infections, infections that may be related to FMT, and worsening of existing comorbidities or development of new comorbidities for the 12 months post-FMT with the option of participating in long-term follow-up for up to 5 years post-FMT. Patients will provide stool samples 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, and 12 months post-FMT. These samples will be testing for ESC-R Enterobacteriaceae.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Fecal Microbiota Transplantation as a Strategy to Eradicate Intestinal Carriage of Resistant Organisms
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Fecal Microbiota Transplantation
Subjects will receive 50mL of prepared stool fecal via nasogastric tube
Biological: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation




Primary Outcome Measures :
  1. Safety and Tolerability of FMT as measured by Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events [ Time Frame: 12 months post-FMT; optional long-tern follow-up for 5 years post-FMT ]
    Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events


Secondary Outcome Measures :
  1. Efficacy of FMT [ Time Frame: 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, 12 months post-FMT ]
    Proportion of subjects free from ESC-R intestinal colonization and recurrent ESC-R infections 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, and 12 months post-FMT



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children and adolescents between 7 and 21 years of age.
  2. A history at least one infection due to ESC-R Enterobacteriaceae. ESC-R isolates will be defined as those non-susceptible to ceftriaxone, cefotaxime, or ceftazidime.
  3. Parent/guardian and participant must be able to attend baseline and follow-up study visits.
  4. Subject must be willing and able to provide written informed consent or assent (as appropriate by age).

Exclusion Criteria:

  1. Patients with any history of malignancy or any immunocompromised state (e.g. absolute neutrophil count outside the normal range) induced by disease or therapy will be excluded.
  2. Patients with past or current use of systemic immunosuppressive agents will be excluded. Receipt of non-systemic agents such as inhaled, nasal, or topical steroids or immune-modulating agents are allowed.
  3. Lack of intestinal carriage of ESC-R Enterobacteriaceae (negative selective stool culture for ESC-R Enterobacteriaceae).
  4. Allergy or hypersensitivity to omeprazole and polyethylene glycol.
  5. Pregnancy.
  6. Current history of frequent (>1 per week) vomiting.
  7. Active inflammatory gastrointestinal disease, such as inflammatory bowel disease
  8. Active mucositis or acute graft versus host disease of the gastrointestinal tract
  9. Concurrent abdominal radiation therapy.
  10. Inability to tolerate nasogastric tube placement or contraindication to having an NG tube placed.
  11. Presence of a ventriculoperitoneal shunt or other intrabdominal device, receipt of renal dialysis, presence of ascites, or other conditions/devices that would increase the risk of peritonitis.
  12. Bleeding diatheses
  13. Patients with current active ESC-R Enterobacteriaceae infection who have not yet completed antibiotic treatment will be excluded until their treatment is completed

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543866


Contacts
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Contact: Amanda Adler 206-884-5086 amanda.adler@seattlechildrens.org

Locations
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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Danielle M Zerr, MD, MPH    206-987-2653    danielle.zerr@seattlechildrens.org   
Contact: Amanda Adler, BA    206-884-5086    amanda.adler@seattlechildrens.org   
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
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Principal Investigator: Danielle Zerr, MD, MPH Seattle Children's Hospital

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Responsible Party: Danielle Zerr, Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02543866     History of Changes
Other Study ID Numbers: 15587
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No